CAPIOX®FX CX*FX25RERecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04987350701022), received between Jun 22, 2017 and May 6, 2026 — classified as 4 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Leak/Splash; Air/Gas in Device

  TERUMO RECEIVED THE FOLLOWING REPORTED INFORMATION: THERE WAS AIR IN THE FILTER. THE EVENT OCCURRED DURING BYPASS, THE PATIENT WAS INVOLVED. THE END OF THE PROCEDURE (4 HRS 12 MIN), THIRD PARTY TUBING PACK. THE PROCEDURE WAS NOT DELAYED, AND THE DEVICE WAS NOT REPLACED. THERE WAS NO IMPACT ON PATIENT, PATIENT TREATED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25102146 ↗
• MalfunctionNov 21, 2024Lack of Effect; Lack of Effect

  THE USER REPORTED THAT THE POSITIVE PRESSURE RELIEF VALVE MIGHT NOT BE FUNCTIONING. THE EVENT OCCURRED DURING THE OPERATION. THE PATIENT WAS NOT HARMED, AND NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT INJURY OR BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20742089 ↗
• MalfunctionApr 22, 2024Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE TUBING CONNECTION HAD WATER LEAKAGE. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19151886 ↗
• MalfunctionMar 2, 2024Backflow; Backflow

  THE USER FACILITY REPORTED THAT DURING THE PERFUSION PROCEDURE WITH THE ENTIRE SYSTEM SUPPLIED (RESERVOIR, OXYGENATOR, TUBING PACK SET) DURING SURGERY. INITIALLY FULLY FUNCTIONAL, AFTER CLAMPING THE AORTA PLUS CARDIOPLEGIA, IT BECAME APPARENT THAT NO CORRESPONDING BACKFLOW/CARDIAC RELIEF WAS ACHIEVED. DESPITE THE SUPPORT OF SUCTION, THE SITUATION COULD NOT BE IMPROVED. THE ERROR WAS DETERMINED TO BE THAT THE RUBBER STOPPER ON ONE OF THE 6 STANDARD SUCTION ADAPTERS ON THE RESERVOIR CAME LOOSE/WAS LOST - FOR NO IDENTIFIABLE REASON. BY CLOSING THE PORT, SUCTION COULD BE REBUILT, AND EFFICIENT DRAINAGE WAS ESTABLISHED. THE EVENT OCCURRED INTRA-OPERATIVE. NO PATIENT INVOLVEMENT. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18823410 ↗
• MalfunctionJan 22, 2024Crack; Crack

  THE USER FACILITY REPORTED LINE/HOLE DAMAGE WITH THE CAPIOX DEVICE INVOLVED. WHILE PRIMING, PERFUSIONIST DETECTED A CRACK IN THE POST OXY PRESSURE LINE. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550618 ↗
• MalfunctionSep 28, 2023Gas Output Problem; Gas Output Problem

  THE USER FACILITY REPORTED THAT THE INVOLVED DEVICE OXYGENATION WAS LOW. THE PATIENT WAS ON BY-PASS DURING AN MVR AND THE AORTA WAS CLAMPED. THE PERFUSION OPERATOR NOTICED THAT A FLOW THROUGH THE OXYGENATOR WHEN SUTURES WERE PLACED ON THE VALVE. THE OXYGEN EXCHANGE WAS ON APPROXIMATELY 50%. AS THE CARDIAC SURGEON REQUESTED ADDITIONAL TIME TO COMPLETE THE TREATMENT, A DECISION WAS TAKEN TO REPLACE THE OXYGENATOR INTO A NEW ONE (ALSO TERUMO). THE OXYGENATOR EXCHANGE LASTED APPROXIMATELY 10 MINUTES. BLOOD LOSS WAS DUE TO THE ENTIRE SET EXCHANGE WHICH INCLUDES OXYGENATOR, RESERVOIR, AND TUBING SETS. THE EVENT OCCURRED INTRA-OPERATIVE. THE PROCEDURE OUTCOME WAS COMPLETED SUCCESSFULLY. THE FINAL PATIENT IMPACT WAS NOT HARMED. THOUGH NO HEALTH HAZARD ATTRIBUTABLE TO THE EVENT WAS REPORTED, JUDGED AS SERIOUS INJURY BECAUSE THE PRODUCT WAS CHANGED OUT. THE PATIENT REQUIRED MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17840885 ↗
• MalfunctionFeb 14, 2023Increase in Pressure; Increase in Pressure

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE INVOLVED HAD HIGH PRESSURE. THERE WAS DIFFICULT CANNULATION, ARTERIAL 21 FOR HLS CANNULA ARTERIAL FEMORAL IS RIGHT. VENOUS CANNULATION VERY DIFFICULT, INITIALLY (FOR ALMOST THIRTY (30) MINUTES) VENOUS BACKFLOW WAS ONLY POSSIBLE VIA SUCTION. CANNULATION WAS DONE VIA THE SUPERIOR AND INFERIOR VENA CAVA. TO OBTAIN BETTER VENOUS RETURN, THE VENOUS VACUUM THERAPY (SEVACO) WAS APPLIED. CONTINUOUS BLOOD CLOTS WERE SUCTIONED VIA THREE SUCTION UNITS. BLOOD FLOW AT THE BEGINNING WAS ABOUT 70% (=3.7 L/MIN), LATER WITH SUFFICIENT BACKFLOW IT WAS 100% (=5-5.3 L/MIN). ACT WAS IN THE NORMAL RANGE (=>500 S) EXCEPT FOR THE LAST 344S; THEREFORE 5000 IU HEPARIN WAS ADMINISTERED. TIME ON BYPASS WAS 249 MINUTES. AORTIC CLAMP TIME WAS 97 MINUTES. REPERFUSION TIME WAS 80 MINUTES. AFTER ABOUT 2 HOURS OF BYPASS TIME, IT WAS NOTICED THAT THE BLOOD BAG WAS INFLATED. THUS, IT WAS INFERRED IT HAD TO BE AN OVERPRESSURE ON THE SIDE OF THE CARDIOTOMY RESERVOIR. THE PRESSURE WAS SO HIGH THAT THE BLUE END CAP WAS CATAPULTED 3/8 INCH OFF THE RESERVOIR. AFTER INCREASING THE SUCTION SEVERAL TIMES FROM -25 MMHG TO FINALLY -80 MMHG; HOWEVER, THERE WAS NO IMPROVEMENT. THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16374079 ↗
• MalfunctionJul 17, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE PATIENT HAD BEEN ON BYPASS FOR FIVE HOURS WITH NO UNUSUAL INCIDENTS HOWEVER THE PO2 WAS EXTREMELY LOW ON REWARMING EVENTUALLY RESULTING IN A PO2 OF 7MMHG WITH AN FIO2 OF 100%. THE CASE WAS QUITE COMPLEX AND UNIQUE WHICH REQUIRED AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) MACHINE IN THEATRE WHICH THE PATIENT WAS PLACED ONTO WITH NO HARM OCCURRING (IT WAS ALWAYS THE PLAN TO INITIATE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)). IT WAS NOT NECESSARY TO RE-ESTABLISH CARDIOPULMONARY BYPASS. THERE WAS NO NEED FOR MEDICAL INTERVENTION AND THE PROCEDURE WAS PERFORMED AS INTENDED. THE OXYGENATOR WAS NOT REPLACED AS WE WENT ONTO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AS PLANNED. THERE WAS NO ADDITIONAL IMPACT ON THE PATIENT AS A RESULT AND THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15036809 ↗
• InjuryJun 20, 2022Air/Gas in Device; Air/Gas in Device

  THE USER FACILITY REPORTED AIR IN THE MEMBRANE OF THE CAPIOX DEVICE INVOLVED. THE PATIENT HAD BEEN IN CEC FOR ROUGHLY TWO MINUTES. WHEN THE PERFUSIONIST NOTICED THE AIR, IT WAS ASKED THAT THE PATIENT BE REMOVED FROM CEC. AFTER THE PATIENT WAS REMOVED, THE MEMBRANE WAS REPLACED. AFTER THE MEMBRANE WAS REPLACED, THE SURGERY CONTINUED AS NORMAL WITHOUT INTERCURRENCES. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY, MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742422 ↗
• MalfunctionDec 1, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE CONNECTOR OF SAMPLE LINE COULD NOT BE FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE EVENT OCCURRED PRE-TREATMENT, THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907515 ↗
• MalfunctionDec 1, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE CONNECTOR OF SAMPLE LINE COULD NOT BE FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE EVENT OCCURRED PRE-TREATMENT, THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907486 ↗
• MalfunctionNov 30, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE CONNECTOR OF SAMPLE LINE COULD NOT BE FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE EVENT OCCURRED PRE-TREATMENT, THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891797 ↗
• MalfunctionNov 30, 2021Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE CONNECTOR OF SAMPLE LINE COULD NOT BE FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE EVENT OCCURRED PRE-TREATMENT, THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891647 ↗
• MalfunctionOct 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT. THE CONNECTOR OF SAMPLE LINE CAN'T FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE USER CHANGED WHOLE OXYGENATOR BY NEW ONE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561735 ↗
• MalfunctionOct 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT. THE CONNECTOR OF THE SAMPLE LINE CANNOT BE FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE USER CHANGED THE WHOLE OXYGENATOR BY NEW ONE. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561630 ↗
• MalfunctionSep 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT. THE CONNECTOR OF SAMPLE LINE COULD NOT BE FIXED, EASY TO DIS-CONNECT DURING THE PRIMING. THE USER CHANGED WHOLE OXYGENATOR BY NEW ONE. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12539152 ↗
• MalfunctionJul 31, 2019Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE HAD A BROKEN SAMPLING SYSTEM. THE BREAK WAS FOUND AFTER OPENED THE TYVEK BAG. THE EVENT OCCURRED PRE-TREATMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8846257 ↗
• MalfunctionDec 19, 2018Improper Flow or Infusion; Improper Flow or Infusion

  THE USER FACILITY REPORTED LACK OF OXYGENATION AT THE END OF THE CEC WITHOUT ALTERING THE PRESSURE DROP WITH THE INVOLVED CAPIOX DEVICE. ACT IN THE RANGES, WORKING GAS BLENDER. AFTER MITRAL REPAIR IN MINITECTOMY, DURING THE PHASES OF WEANING FROM THE CEC THERE WAS A SUDDEN CHANGE IN BLOOD COLOR IN THE ARTERIAL CANNULA, WHICH TURNED DARK. THE MECHANICAL VENTILATION WAS ACTIVATED AND, WITHIN A FEW SECONDS, THE PATIENT WAS WEANED BY THE CEC, WITH GOOD HAEMODYNAMIC AND OXYGENATION PARAMETERS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8178321 ↗
• MalfunctionJun 29, 2018Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED LEAKAGE ON THE INVOLVED CAPIOX DEVICE. THERE WAS A LEAK IN THE OXYGENATOR. IT WAS REPORTED THAT MOST LIKELY FROM BLOOD SIDE TO GAS SIDE. THERE WAS NO PATIENT INVOLVEMENT. THE PROCEDURE OUTCOME IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7650476 ↗
• InjuryJun 28, 2018Device Operational Issue; Device Operational Issue

  THE USER FACILITY REPORTED DURING A CARDIOPULMONARY BYPASS THEY HAD A FAILURE WITH THE PUMP ON THE INVOLVED CAPIOX OXYGENATOR . THEY WENT ON BYPASS AND IMMEDIATELY SAW NO COLOR CHANGE AND THE VENOUS STATS WERE DROPPING. THEY WENT OFF BYPASS WITHIN A MINUTE OF GOING ON BYPASS, THEY INITIALLY THOUGHT THE ISOFLURANE WAS BLOCKING THE OXYGEN. THEY WENT ON BYPASS AND RECIRCULATED THE BLOOD FOR A FEW MINUTES AND DID A GAS. THE P02 WAS 56, THEY REPEATED IT AND THE P02 ONLY WENT UP TO 82. THEY DECIDED IT WAS THE OXYGENATOR AND CHANGED IT OUT. THEY DID A GAS, AND THE P02 WAS OVER 800. THERE WAS A FOUR-MINUTE DELAY. THERE WAS NO BLOOD LOSS. THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7645807 ↗
• MalfunctionJun 13, 2018Fracture; Fracture

  THE USER FACILITY REPORTED A TUBE FRACTURE ON THE INVOLVED CAPIOX DEVICE. WHEN THE DOCTOR ASSEMBLED THE CBP CIRCUIT PRE-TREATMENT, IT WAS NOTICED THAT PURGE LINE WAS SEPARATED FROM THE PORT. THE PROCEDURE OUTCOME IS UNKNOWN.

  Patient problems: No Patient Involvement

  MAUDE report 7595533 ↗
• InjuryJan 16, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE MALFUNCTION DURING USE IN ECC WITH SEVERE DESATURATION OF THE ARTERIAL BLOOD WITH 100% FIO2 GAS SETTING. THE PROCEDURE OUTCOME IS UNKNOWN. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7194815 ↗
• MalfunctionAug 1, 2017Break; Break

  THE USER FACILITY REPORTED BREAKAGE IN THE CAPIOX DEVICE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY PROVIDED THE FOLLOWING INFORMATION: THE USER FOUND THE CONNECTOR HAD BROKEN AFTER OPENING THE PACKAGE; IT WAS REPLACED WITH A NEW ONE; AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6759110 ↗
• InjuryJun 22, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED A PLASMA LEAK IN THE CAPIOX DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: CEC PROCEDURE WAS BEING CONDUCTED AT A TEMPERATURE OF 30 DEGREES; AFTER 1 HOUR AND HALF AN OXYGENATION DEFICIENCY OCCURRED; THIS REQUIRED THE FI02 SETTING TO 100% TO OBTAIN A PAO2 OF 80MMHG; SUBSEQUENTLY THE DEVICE BEGAN TO FOAM FROM THE GAS OUTPUT OF A TYPICAL YELLOW COLOR; THE DEVICE WAS CHANGED OUT DUE TO LEAKAGE PLASMA; AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6659545 ↗